Linda Kirk (SA, Australian Labor Party) Share this | Hansard source

I also rise this evening to speak in favour of the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 and to outline the reasons why I support the removal of the ministerial power of approval of RU486 and other abortifacients from the Minister for Health and Ageing and its transfer to the Therapeutic Goods Administration, or TGA. As many other speakers have noted, this debate has been clouded by issues which, although they are of considerable social significance, are not the subject of this legislation. We are not, here, being asked to determine whether access to abortion should be legal in Australia. The states and territories have legislative power over the subject matter and the various parliaments have legislated to provide for the circumstances in which a woman may lawfully terminate an unwanted pregnancy.

As many speakers have said, this issue has already been decided and was done so some 30 years ago. Australian women have already won the right to access legal abortion, and there are no moves afoot within the states and territories to change the existing law. Australians continue to be overwhelmingly in favour of a woman’s right to choose. According to the latest Australian Survey of Social Attitudes, in 2003, 81 per cent of Australians said that a woman should have the right to choose whether or not to have an abortion. I am one amongst this overwhelming majority of Australians. Nor are we being asked to determine whether RU486 is safe. This has, however, been the focus of much of this debate and it is therefore a matter that I will briefly address in my remarks today.

What we are being asked to determine is the process by which there may be access by Australian women to a method of abortion that is accessed by thousands of women worldwide. The issue is whether this drug should be dealt with like any other drug. It really is a straightforward question: should the minister for health have the power to determine the safety, efficacy and quality of the drug RU486 or should this decision be given to the TGA?

As we are all aware, today the Senate Community Affairs Legislation Committee released its report summarising the findings of the inquiry into this bill. I have had the chance to read the majority of the report, and I commend both the senators and the committee secretariat for a most comprehensive report that clearly sets out the issues in this debate. According to its website, the committee received over 2,300 submissions, as well as 2,160 of what might be described as anti-choice letters and some nine pro-choice letters. Like most other senators, I have received hundreds of emails and letters on this issue. In fact, just before I came down here tonight I checked my in-box and found some 40 additional emails that I had received in the last hour or so. The majority of those that I have received are from people who oppose abortion full stop. Many others question the safety of the drug RU486, citing serious side effects and the deaths of women overseas.

But this bill is about neither of these issues. With respect to all of the people who wrote to me and to other senators, this bill is not about proposing to change existing laws. As I said before, this bill does not propose to, nor can it, change existing state and territory laws in relation to abortion; nor does it seek to make a determination of the safety or otherwise of RU486. This bill is about the process by which RU486 should or should not be approved for use in Australia. It proposes to give the TGA, rather than the minister for health, the responsibility for approval of the drug.

I support the objective of the bill, as I believe that placing the responsibility for approval of RU486 with the minister is inappropriate for the following reasons. First, the minister for health does not have the capacity for, or specific expertise in, assessing the safety and efficacy of therapeutic agents. I say this in relation to not only the current minister for health, with respect, but all ministers for health, be they past, present or future. In fact, I think it is the case that very few, if any, members of parliament or members of the government have the capacity to make this assessment.

Secondly, singling out drugs such as RU486 for ministerial approval does not improve the safety of drug regulation and prescription in Australia. Much has been made in this debate about the need for there to be political accountability in the making of the decision on whether to approve the drug RU486. The democratic process requires that the government act in the interests of the people it represents, yet here the existing process allows just one person, the minister for health, to make the decision on whether or not to approve the drug for use in Australia.

The present system precludes the role of the TGA from the process of evaluating medications such as RU486 without the written approval of the minister. The act does not require that the minister seek advice or that he or she give any reasons or follow any protocol when making a decision regarding an application in relation to these drugs. Every other drug is evaluated by the TGA solely on its scientific merits, without ministerial involvement, subject to clear standards of accountability and transparency for evaluating clinical evidence. We in Australia are well served, I believe, by the professional competence and integrity of the TGA. That clearly came out during the committee’s inquiry. There is no reason at all to exclude one group of therapeutic agents from the act by having a separate process such as that which exists for the drug RU486.

I said that I would make a few comments in relation to the issue of the safety of the drug. As I said at the outset, I certainly do not profess to have any expertise in this area; I cannot make an assessment of the safety or otherwise of the drug. That really is something that ought to be left to the experts. I would prefer that safety were not part of this debate because, as I said in my introduction, this bill is not about whether RU486 is safe but about who is qualified to decide.

This is what we know about RU486. Two million women in 35 countries have chosen to use the drug. It has been subject to numerous studies and wide scrutiny. The US based Association of Reproductive Health Professionals says it is safer than aspirin, Tylenol and Viagra. RU486 has been judged as safe by the Australian Medical Association, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the Rural Doctors Association, the National Association of Specialist Obstetricians and Gynaecologists and many other individual members of the medical profession.

Many medications are unsafe or need monitoring under certain circumstances. GPs are trained to know when to prescribe drugs or treatments. They do not have a one-size-fits-all approach and they are careful to weigh up an individual’s physical and mental health and social situation and to know when to exercise caution or to suggest other options. This is what they are trained to do.

In the time I have remaining I want to make brief mention of the fact, as other speakers have, that RU486 has applications other than the termination of pregnancy, some of which are potentially life saving—or would be if patients were able to access them. Patients with certain brain tumours and endocrine conditions have been told by their doctors that RU486 would be the best possible treatment, but under the current system they are unable to receive this treatment. I am informed that some of the people in this situation have been through the arduous process of getting approval from the TGA to import the drug. However, there is a catch: because by necessity the approval can only be limited, it is not covered by medical indemnity insurance and so they are often unable to find a doctor who is willing to prescribe the drug.

In closing I say that it is time we had this debate and I welcome it. In 1996 the drug RU486 was effectively banned. For 10 years Australian women have been prevented from choosing what, for many, would have been the safest method of abortion. There are 35 countries, including the United States, Britain and New Zealand, which have judged RU486 to be safe. Most Australians support a woman’s right to choose. However, as I said in my opening remarks, this bill is not about the legality of abortion, nor is it about whether RU486 is safe. Whether RU486 is safe is something that should be left to the TGA, an organisation eminently qualified for this decision. In my view this is something that the medical experts ought to decide and for that reason I will be supporting this bill.